Your healthcare provider should do blood tests to check how well your liver is working before you begin treatment with IXEMPRA and as needed during treatment. If blood tests show that you have liver problems, do not receive injections of IXEMPRA along with capecitabine. If you have liver problems, taking these medicines together could increase your chance of serious infection and death due to a very low white blood cell count (neutropenia).

You should not have your injection of IXEMPRA if you are allergic to medicines that contain Cremophor® EL* (polyoxyethylated castor oil) or if you have a low white blood cell count or a low platelet count. Continue to full Important Safety Information below

IXEMPRA a prescription medicine, used to treat breast cancer when certain medicines have not worked or no longer work can be used alone or with capecitabine.

Serious Side Effects of IXEMPRA® (ixabepilone)

Some women have had serious side effects when they received IXEMPRA. You should know that these side effects could happen. Because of these serious side effects, IXEMPRA may not be right for everyone. If you have any of these side effects, talk with your healthcare provider right away.

Below is a list of the serious side effects. Click on a side effect to learn more about it.

Tingling, numbness, or burning in the hands or feet, or extreme
sensitivity to touch (peripheral neuropathy)

Peripheral neuropathy (PN) is an unpleasant feeling in the hands and feet that is caused by nerve damage. This can lead to problems, such as weakness, balance problems, and trouble walking. Your dose of IXEMPRA may need to be lowered or stopped until these symptoms get better. Or you may need to stop taking IXEMPRA permanently. Be sure to follow your healthcare provider’s advice on ways to manage PN.

In one clinical trial, 67% of women who received IXEMPRA and Xeloda had PN

In another clinical trial, 63% of women who received IXEMPRA alone had PN

Low white blood cell count (neutropenia)

Having a low white blood cell count means your body cannot fight infections very well and you have a greater chance of getting an infection. Signs of infection can include fever (temperature over 100.5°F), chills, cough, and/or burning or pain when urinating. If you get a fever or infection when your white blood cells are very low, you can become seriously ill and die. You may need treatment in the hospital with antibiotic medicines. Your healthcare provider will monitor your white blood cell count often with blood tests. Tell your healthcare provider right away or go to the nearest hospital emergency room if you have signs of infection.

In one clinical trial, 36% of women who received IXEMPRA and Xeloda and 2% of women who received Xeloda alone had severe neutropenia

In another clinical trial, 23% of women who received IXEMPRA alone had severe neutropenia

Severe allergic reaction

Some women who receive IXEMPRA have a severe allergic reaction to it. In rare cases, these allergic reactions may cause death. It may help you to know:

There are medicines that may help lower your chances of having an allergic reaction. You will receive these medicines an hour before each treatment with IXEMPRA

Allergic reactions usually happen while people are receiving IXEMPRA. Your doctor or nurse will watch you closely for signs of an allergic reaction

But you should also be aware of the signs of an allergic reaction. Watch for:

Itching, hives, or rash

Flushed (red) face

Sudden swelling of the face, throat, or tongue

A tight feeling in the chest or trouble breathing

Feeling dizzy or feeling like you are going to faint

Feeling a strong, rapid heartbeat (palpitations)

Tell your healthcare provider right away if you have symptoms of an allergic reaction during treatment with IXEMPRA. Call your healthcare provider if an allergic reaction starts after your treatment is finished and you are at home.

Harm to an unborn child

You should not receive IXEMPRA during pregnancy because it may cause harm to an unborn child. Talk with your healthcare provider about how to prevent pregnancy during treatment with IXEMPRA. Tell your healthcare provider right away if you become pregnant or think you are pregnant while receiving IXEMPRA.

Heart problems

Heart problems may happen when the heart does not pump blood properly. This may mean that less blood flows to the heart. This can cause chest pain, trouble breathing, palpitations (being able to feel your heart beating), and unusual weight gain. In clinical trials, heart problems were reported by:

2% of women who received IXEMPRA and Xeloda

Less than 1% of women who received Xeloda alone

What Is IXEMPRA® (ixabepilone)?

IXEMPRA is a prescription medicine used to treat locally advanced or metastatic breast cancer following certain treatments. IXEMPRA can be used alone or with another cancer medicine called Xeloda® (capecitabine).

Talking With Your
Treatment Team About IXEMPRA

You may want to ask your healthcare provider:

  • What should I do if I think I am having a serious side effect?

IXEMPRA is a trademark of Bristol-Myers Squibb Company.
*Cremophor is a registered trademark of BASF AG.
Xeloda is a registered trademark of Roche Laboratories.
© 2010 Bristol-Myers Squibb, Princeton, New Jersey 08543 U.S.A. All rights reserved.

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Chemotherapy

A type of cancer treatment that uses certain medicines to destroy cancer cells. It can also harm healthy cells

Breast Cancer

A type of cancer treatment that uses certain medicines to destroy cancer cells. It can also harm healthy cells

Anthracycline

A type of medicine that damages the DNA in cancer cells, causing them to die

Anthracycline

A type of medicine that damages the DNA in cancer cells, causing them to die

Locally advanced

Cancer that has spread from the breast to nearby tissue or lymph nodes

Lymph nodes

Small masses of tissue that are an important part of the immune system. The lymph nodes act as filters that trap harmful things in the body

Metastatic

Cancer that has spread from the breast to other parts of the body

Preauthorization

When the insurance company decides if a treatment is medically necessary for the patient and will be paid for by the insurance company

Taxane

A type of medicine that stops cancer cells from dividing

Locally advanced

Cancer that has spread from the breast to nearby tissue or lymph nodes

Metastatic

Cancer that has spread from the breast to other parts of the body

Locally advanced

Cancer that has spread from the breast to nearby tissue or lymph nodes

Locally advanced

Cancer that has spread from the breast to nearby tissue or lymph nodes

Locally advanced

Cancer that has spread from the breast to nearby tissue or lymph nodes

Metastatic

Cancer that has spread from the breast to other parts of the body

Taxane

A type of medicine that stops cancer cells from dividing

Anthracycline

A type of medicine that damages the DNA in cancer cells, causing them to die

Lymph nodes

Small masses of tissue that are an important part of the immune system. The lymph nodes act as filters that trap harmful things in the body